Preparation containing dextranase

ABSTRACT

THIS DISCLOSURE RELATES TO STABLE EFFERVESCENT DENTURE SOAK COMPOSITIONS CONTAINING DEXTRANASE PARTICULARY USEFUL IN REDUCING DENTAL PLAQUE.

3 630 924 PREPARATION coisrxiismc DEXTRANASE Glendon Richard Miller, Basking Ridge, NJ., ass'gnor to Colgate-Palmolive Company, New York, N.Y.

250 ml. of a medium containing 0.5% yeast extract and 1% tiextran. The flasks are incubated at 30 C. on a 71 )tR 39630992 14 2o O 3,630,924 w J Patented Dec. 28, 197i shaking incubator for 4 days. The culture is then centrifuged at 3000 g. for 20 minutes and filtered through Whatman 42 filter paper. Dialysis in 16 mm. Visking" tubing against deionized water and concentrating fifty- 5 fold by dialysis against polyethylene glycol (molecular No Drawmg' fggg i g g 793577 weight 20,000) follows. The dextranase produced in ac- 5 cordance with this procedure has a molecular weight of US. Cl. 252-100 C aims about 200,000-275,00. if desired, the dextranase may be further purified by fractionation with ammonium sulfate. ABSTRACT OF THE DISCLOSURE 10 A further method for preparing dextranase is described in US. Pat. 2,742,399 to Tsuchiya et al.

This disclosure relates to stable effervescent denture The amount of dextranase employed in the oral prepa compqsmons comammg dextranase particularly ration of the invention is at least such amount as is efiecful m reducmg dental plaque tive in promoting oral hygiene. This amount is dependent upon the activity of the dextranase and therefore upon the mode of its preparation. A typicall pre ared dextranase The present mvemion a stable cficrvcscem enzyme material has an activity of 500 u r iits/mg. where l demure preparanop comammg dextranasg unit is the amount of enzyme which produces 1 mg.

The an 15 repleieyuh i q i .demure soak equivalent of isomaltose monohydrate in 1 hour at 40 mulae; some of which contain oxidizing agents as the C. at pH SJ on dextrose (Note Tsuchiya et a1" source of efi'ervescence, others comprising a carbonate Journal of Bacteriology vol 64 page 513) as the source of carbon dioxide liberation, and still others whilc smaller amoums extranase be used a unhzmg both an oxldlznig agent and carbopanon agents dextranase enzyme material such as that described above (a carbonate plus an acid capable of reacting to release may be pxsem in amounts of about 0.001704% by Garbo!) dloxide) m a Single composmon' 25 weight of the denture soak preparation, preferably about While prior art denture soak formulations were efiecand most preferably about 113% The five as cleansers the accumulated plaque. resisted amounts refer to the amount of dextranase in the matemoval. Even the cumbersome act of brushing the denrial. The material is generally in crude form tures was ineffective in completely removing the plaque The emcacy of the dextranase containing product is which l i q g l attributed to its ability to degrade microbially produced mg n an o Ject o t mvemwnp prov] e extra-cellular polysaccharides of the dextran type which a stable $021k product capable of removmg and/or are present in plaque matrix. During the course of the i the mlcjldence of Plaque' bl E d day, micro organisms in the mouth colonize the dentures t has now can found that a c e ervescem and build dextran which forms the basis for dental plaque. i soak Product capable of reducmg dental plaquiwhen The instant product is particularly effective in reducing dlssolved water can be.f.rmu]ated y the iq p the incidence of plaque and protecting the dentures against dextranase to a composition comprising an oxidizing dccay i morgamc carbonic and an acld' Th8 The source of carbon dioxide is a water soluble alkaliinorganic carbonate reacts with the organic acid to release metal carbonate compound selected from thc group com cilrbon dloxllje winch effervesce? an aqueousf g 40 sisting of sodium bicarbonate, sodium carbonate, sodium i i f with h evolution of oxygen mm e sesquicarbonate, potassium carbonate, potassium bicaroxldlzmg agent relgasmg the dcxiranase to attack the bonate, and mixtures thereof, which reacts with a solid dextrall whlch forms foundauo? f dental l non-toxic organic acid selected from the class consisting Cessation of efiervescence does not signify completion of of tartaric acid citric acid malic acid maleic acid mzymanc acnmy whch "9 long pcnods of fumaric acid, succinic acid, adipic acid, etc. and mixtures at smtable Accordmgiyi thc (Futures are thereof, in the presence of water to produce eifervescence ably Soaked overmgm at a shghtly prcfcr'ilbly (bubbles). The carbonate content and acid content may at a pH of 5-5.5. These novel denture soak formulations each vary from about 5 50% and preferably 10 3o% must be stable over along period of time and yield an by weight of the total composition WMMTQ W?HHQJPHQMU1}EPIlyicld-pfi-iQLgpllmlmIPZY- 1 5 It is preferable to utilize anhydrous acids to preserve mam siablmi'f and E shelf stability of the dry formulation and to prevent prespecifically thls mvemwn relate-5 P a mature carbon dioxide evolution prior to its dissolution non-deliquescent water soluble effervescent solid composiin Wat shghlyfcld PH dissolved aqueous The oxidizing agents offer another source of effervesmedium comprising a solid water soluble oxidizing agent, can (liberation of oxygen) and are preferably the a solid water soluble carbofmcfompoundi 50nd persalts such as the alkali metal perborates, persulfates, hydrous Ofgamc l and q r percarbonates, perphosphates and the like. The simple Dextranaseis an enzyme material which is effective in addition f m soluble pal-oxygen compounds to g the mcldencc of dfmal 1 l and ax P"- water produces a highly effective effervescent fiow of active P fi m a mold growl} ff i f 6 oxygen which is particularly useful in oxidation reactions, tran, in the manner described by Bowen, Brit s D= thereby providing considerable improvements in applicalournal; 8, APTII 16, 1963, P 8 tions where peroxygen compounds are employed such as Bmflymay be Prcpamd from noncanogemc for antiseptic, cleansing and bleaching activity. The degree smlltococcfll Strains such as Q 10558 9({3-160O, of efiervescenoe which relates to both the volume and speed lIA2 +3 or Leuconarloc mesentertozdes and purifiedaci dependent on th particular peroxygen compound emcording to the method described by Wood et al., Archives ployed' For examplc sodium pcrborate has three times of EY| Y 1955 1 8 et seq! P as much active oxygen as potassium persulfate, but the t mewlfmmdis 15 Brown at 25 latter has a stronger oxidation potential (stronger oxidiz- Dflifanasfl y B150 be p f from denial} Y ing agent, and is less effected by moisture. Consequently. inoculating Penicillin mfum'culosum into flasks containing it may be preferable to use a mixture of persalts in order to obtain the combined advantages of both oxidizing agents. The total amount of oxidizing agents utilized therein may vary from -50% and preferably -30% by weight of the total composition, the distribution between the various agents being dependent on the desired end result. More specifically, a composition having less active oxygen but yielding stronger oxidizing action will utilize a greater amount of the persulfate salt, whereas a formulation requiring a greater and quick release of active oxygen will employ a greater amount of the perborate. Other suitable solid per-oxygen compounds include ammonium persulfate, sodium persulfate, sodium pyrophosphate peroxide, sodium carbonate peroxide, etc.

The denture soak composition may also contain any suitable surface-active or detersive material to enhance its cleaning activity. Suitable detergents are water soluble nontoxic salts of higher fatty acid monoglyceride, monosulfate, higher alkyl sulfate, alkyl aryl sulfonate, higher alkyl sulfoacetate, higher fatty acid ester of 1,2 dihydroxy propane sulfonate, higher fatty acid amides of taurine and higher fatty acid esters of isothionic acid; the substantially saturated highed aliphaitc acyl amides of lower aliphatic amino carboxylic acid compounds, such as those having 12 to 16 carbons in the acyl radical, and the like. Examples of such amides are N-lauroyl, myristoyl or palmitoyl sarcosides. The various surface-active materials should be used in a suitable amount such as up to about 5%, preferably from about 0.1 to 5% by weight of the denture soak preparation.

Various other adjuvant materials may also be incorporated in the present denture soak preparations. Water soluble halides such as sodium chloride may be added which provide a source of free halogen in aqueous solution for additional oxidizing and cleaning effects. Minor amounts of flavor oils such as oils of spearmint, peppermint and Wintergreen may be included to impart a mild and pleasant flavor and odor to the cleaned denture. However, when adding a flavor oil in amounts not exceed ing 0.25%, it has been found desirable to also incorporate minor amounts about 1-5% of a flavor retainer or carrier such as magnesium carbonate to avoid the separation of the oil droplets from the rest of the dry composition. Other flavor retainers may be utilized provided they readily absorb the flavor oils and prevent fiavor weeping. Minor amounts of other suitable water soluble additives may be included such as sweeteners, foam depressants, preservatives, buffers, fillers, diluents, binders, etc., provided they do not adversely affect the properties and charactertistics of the denture soak product.

The denture cleansing compositions of the instant invention are dry, water soluble powders or granules which may be packaged in bulk in assorted containers or in individual premeasured packets. The product may also be marketed in the form of tablets. It is essential that aforesaid product completely dissolve in water to yield a clean solution having a mildly acid pH, preferably pH 5.0-5.5

for maximum enzymatic activity and stability for the proper cleansing of dentures. An alkaline solution has the disadvantage of hastening the corrosion of metal parts of the dentures, whereas strongly acid solutions tend to etch the dentures.

The term denture includes all kinds of orthodontic appliances such as false teeth, removable dental plates and bridges, artificial teeth and the like.

The following specific example is further illustrative of the nature of the present invention, but it is to be understood that the invention is not limited thereto. The compositions are prepared in the usual manner as indicated,

and all amounts of the various ingredients are by weight unless otherwise specified.

EXAMPLE I Ingredients: Percent by weight Adipic acid, anhydrous 20.0 Potassium persulfate, anhydrous 20.0 Bicarbonate of soda 20.0 Sodium lauryl sulfate 0.5 Sodium chloride 38.5 Dextranase 1.0

The above ingredients are thoroughly mixed and blended to produce a homogeneous powdered mixture which is stable. A denture is immersed in 200 ml. of water containing 4 grams of the above product which effervesces and has a pH of 5.04.5. After soaking overnight, the denture is bright, clean, odorless and substantially free of dental plaque.

It is understood that the foregoing detailed description is given merely by way of illustration and that variations may be made therein without departing from the spirit of the invention. The Abstract given above is merely for the convenience of technical researchers and is not to be given any weight with respect to the scope of the invention.

What is desired to be claimed is:

1. A stable, non-deliquescent, water-soluble, eflervescent solid denture soak composition of about pH 5 to 5.5 when dissolved in an aqueous medium, consisting essentially of from 5 to 50% by weight of a water-soluble alkali metal carbonate, from 5 to 50% by weight of a solid non-toxic water soluble organic acid, from 5 to 50% by weight of an inorganic peroxygen compound and from 0.001 to 5% by weight of dextranase.

2. A composition in accordance with claim 1 wherein the organic acid constitutes 10 to 30% by weight of the total composition.

3. A composition in accordance with claim 1 wherein the water soluble carbonate constitutes about 10 to 30% by weight of the total composition.

4. A composition in accordance with claim 1 wherein the peroxygen compound constitutes about 10 to 30% by weight of the total composition.

5. A composition in accordance with claim 1 which also contains 0.1 to 5% by weight of a non-toxic water soluble surface active salt.

References Cited UNITED STATES PATENTS 2,931,776 4/1960 Howard 252-99 3,105,792 10/1963 White 42450 3,243,377 3/1966 Stolar et al 252-l00 2,498,343 2/1950 Rider et al 252--99 X OTHER REFERENCES Bowen British Dental Journal" vol. 124, No. 8. Apr. 16, 1968, pp. 347-348.

Fitzgerald et al., "Effects of Dextranase on Caries, Jada, vol. 76, February 1968, pp. 301-303.

MAYER WEINBLATT, Primary Examiner US. Cl. X.R. 252-95, 99; 424-50 

